Transfusion-transmitted HIV from seroconverted blood donors has not been identified in England since the introduction of HIV NAT screening

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1 Transfusion-transmitted HIV from seroconverted blood donors has not been identified in England since the introduction of HIV NAT screening Bhavita Vishram

2 Timeline of introduction of microbiological tests for blood donations, UK

3 Window period Developed from Schriber et al NEJM 1996 by Soldan et al Vox Sang 2003; Eurosurveillance 2005

4 The current risk of not detecting an HIV infectious donation is much less than 1 per million donations.

5 Lookback investigations I HIV positive repeat blood donor most recent previous negative donation (MRPD) possibility that previous donation was infectious but not detected donated in window period or false negative. lookback testing archives, tracing fate of components made from MRPD and arranging notification of living recipients. introduction of NAT screening and Ab/Ag assays reduced chance of false negative.

6 Lookback investigations II positive repeat donor donor contacted and offered a post test discussion with a NHSBT clinician. stored archive sample (kept for 3 years) tested in an individual sample HIV PCR test. irrespective of the result, a lookback is often carried out to determine fate of blood components. lookback may not be carried out where other information points to the infection having being acquired a later date. clear history of seroconversion illness credible risk for infection in the donor with postdates the MRPD. the results of all lookbacks are collated by the NHSBT/PHE Epidemiology unit.

7 Case 1 male donor - late 20 s donation in November previous donation March 2016 avidity seroconversion may have occurred within 4 months of donation archive sample HIV PCR negative. history of new female partner after MRPD seroconversion illness in June with high fever, diarrhoea, vomiting and night sweats. NO LOOKBACK CONDUCTED

8 Case 2 male - Mid 40 s donation in January previous donation September one off sexual contact with another male no clear history archive sample was HIV PCR negative LOOKBACK CONDUCTED Red cells transfused - recipient identified, tested HIV negative Platelets transfused recipient identified deceased before lookback conducted

9 Where archive samples test negative on singleton PCR do we need to continue HIV lookback investigations?

10 Data from 1995 to 2008

11 Data from 1995 to 2008 Byrne et al Transfusion

12 Data from 2009 to 2016

13 Results archive samples 65 HIV positive repeat donors 60 seroconverted within 3 years 53 archive samples tested negative 7 3 archive samples unavailable 4 archives not tested due to donor history and avidity showing recent infection

14 Results lookback investigations 33 lookback investigations 32 recipients 10 deceased 18 tested HIV negative 4 outcome unknown NO HIV TRANSMISSIONS WERE IDENTIFIED

15 since the introduction of pooled HIV NAT screening in 2003: 4 HIV window period donations (NAT pick ups) detected by screening; negative on HIV serology but reactive on pooled HIV NAT screening. no cases of HIV transmission detected by lookback investigations since routine NAT screening was introduced within NHSBT.

16 Where archive samples test negative on singleton PCR do we need to continue HIV lookback investigations?

17 NHSBT governance committee recently approved no lookback is needed where archive samples test HIV PCR negative.

18 Conclusion HIV screening has improved in sensitivity over the last 20 years. 4 window period donations have been detected through screening of 21 million donations from number of window period donations not detected through the use of pooled HIV NAT screening will be vanishingly small and lookback has failed to detect any. discontinue lookback investigations where archive samples HIV PCR negative.

19 Acknowledgements Dr Patricia Hewitt Dr Su Brailsford Claire Reynolds Katy Davison All staff in hospitals who have helped in collecting information.